(Roche) Sep 6, 2017 - Roche today announced results from the global phase III ALUR study showing that Alecensa® significantly reduced the risk of disease worsening or death (progression-free survival, PFS) by 85% compared to chemotherapy in patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC), who had progressed following treatment with platinum-based chemotherapy and crizotinib (hazard ratio [HR]=0.15, 95% CI: 0.08-0.29, p<0.001).

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H. Jack West, MD (Posted: September 08, 2017)

The results of the ALUR trial are impressive but not surprising at all. We should expect a second generation ALK inhibitor to be superior to chemotherapy in crizotinib-pretreated ALK-positive patients. The difference is very striking and highly clinically significant in every efficacy endpoint. The efficacy of chemotherapy was rather disappointing overall. But this trial population should not exist for much longer. Today, with alectinib now becoming the first line therapy of choice for ALK-positive questions, the more relevant question is whether a subsequent alternative second generation ALK inhibitor, such as brigatinib, is a better choice than chemotherapy in alectinib-pretreated patients.

(ESMO) August 11, 2017 - ESMO 2017 is once again the place to be for breaking news on cancer research. ESMO 2017, the annual oncology congress organised by the European Society for Medical Oncology (ESMO) in partnership with the European Association for Cancer Research (EACR) will take place in Madrid, Spain, from 8 to 12 September at IFEMA, Feria de Madrid.

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H. Jack West, MD (Posted: August 14, 2017)

It appears that while the PACIFIC trial of durvalumab consolidation after chemoradiation is being presented at ESMO, we won't see data from either the MYSTIC trial (durvalumab/tremelimumab or durvalumab monotherapy vs. chemo doublet first line for advanced NSCLC) or FLAURA (first line osimertinib vs. erlotinib or gefitinib for EGFR mutation-positive advanced NSCLC). We knew MYSTIC is negative for a PFS benefit, so we should perhaps not be surprised that AZ isn't eager to highlight the results, but I think if there were anything favorable to mitigate the disappointment, they'd have tried to stanch the bleeding by presenting the data. I suspect there will be little to encourage us when AZ ultimately deigns to show us real data. More notable is the omission of FLAURA from the ESMO program, a trial reported as positive for a significant improvement in the primary endpoint of PFS that could potentially change practice and broaden the indication for osimertinib to include first line treatment if the PFS benefit is substantial enough. Unless AZ just doesn't want to compete for the limelight with the PACIFIC trial that will likely cause a Beatlemania-reminiscent hysteria by both being an immunotherapy and being positive, this suggests that the results aren't as captivating as some would have hoped. As an alternative, the IASLC may have promised the moon and the stars to AZ to postpone presentation of a high-impact trial for the first time at the World Conference on Lung Cancer, but I would have anticipated that AZ should want to get positive results out on a potentially practice-changing therapy to as broad an audience as possible, as quickly as possible. We'll eventually see what the data show, but I'm disappointed that two of three important lung cancer trials from which we've heard initial results from recent press releases apparently won't be presented at ESMO. Makes you wonder why they're dragging their feet.

(AstraZeneca) July 31, 2017 - AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Imfinzi (durvalumab) for the treatment of patients with locally-advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy.

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H. Jack West, MD (Posted: July 31, 2017)

We have learned from a press release that the PACIFIC trial is positive for a significant improvement in PFS after chemo/radiation for patients with locally advanced, unresectable NSCLC. Because this treatment entails an extra year of IV treatment every two weeks and a cost likely in the range of $180-200K per patient, most experts feel that the PFS benefit should be remarkably long and/or be accompanied by a significant improvement in survival. In this setting, demonstrating a 3-4 month delay in relapse without a survival benefit won't offset the cost in terms of time on treatment for patients or cost to society. The entire lung cancer community looks forward to the presentation of the actual trial data at an upcoming meeting -- I hope at ESMO 2017 (where I will be happy to provide commentary on the detailed findings). If the PACIFIC trial achieves these criteria, it should rightfully become adopted as a new standard of care in this setting. It would be ideal, however, if we can determine which patients are most or least likely to benefit from this extended treatment so that we can concentrate these extra efforts and costs on the patients who will truly benefit from them.